BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3965036 · Received July 29, 2014

    Report

    Report Number
    2953161-2014-00084
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 1, 2014
    Report Date
    October 7, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT MEDICATIONS: AMLODIPINE, ASTEPRO, CALCIUM CARBONATE-VITAMIN D3, PLAVIX, TRICOR, FLOVENT HFA, XOPENEX, LORATADINE, OMEPRAZOLE, PREDNISONE, SIMVASTATIN, AND DIOVAN. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES THAT ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK AND ANEURYSM ENLARGEMENT.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    PATIENT'S WEIGHT UPDATED. OUTCOMES ATTRIBUTED TO ADVERSE EVENT UPDATED. ADDITIONAL INFORMATION ADDED TO EVENT DESCRIPTION. RELEVANT TESTS ADDED. ADDITIONAL PATIENT'S MEDICAL HISTORY ADDED. ADDITIONAL PATIENT MEDICATIONS INCLUDE; LEVALBUTEROL, ZOCOR, CLARITIN, DILAUDID AND PROTONIX. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT WAS IMPLANTED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CAT SCAN (IMAGING DATE UNKNOWN), REVEALED A PROXIMAL TYPE I ENDOLEAK. THERE IS ANEURYSM ENLARGEMENT, AMOUNT IS UNKNOWN. THERE IS NO REINTERVENTION PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REPORTEDLY SHOWED EVIDENCE OF PROXIMAL AND DISTAL TYPE I ENDOLEAKS WITH EVIDENCE OF ANEURYSM ENLARGEMENT OF AN UNKNOWN AMOUNT. THE PROXIMAL TYPE I ENDOLEAK WAS REPORTED TO BE CAUSED BY CONTINUED ANEURYSMAL DEGENERATION OF THE JUXTARENAL AORTA, AND THE DISTAL TYPE I ENDOLEAK WAS REPORTEDLY CAUSED BY CONTINUED ANEURYSMAL DEGENERATION OF THE LEFT COMMON ILIAC ARTERY. ON (B)(6) 2014, AN ADDITIONAL PROCEDURE WAS PERFORMED TO TREAT BOTH ENDOLEAKS. AN AORTIC EXTENDER COMPONENT WAS IMPLANTED FOR PROXIMAL EXTENSION AND A CONTRALATERAL LEG COMPONENT WAS IMPLANTED FOR DISTAL EXTENSION. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF BOTH ENDOLEAKS, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441269 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06498588

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O| R